Trial Outcomes & Findings for Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma (NCT NCT00735306)

NCT ID: NCT00735306

Last Updated: 2015-06-18

Results Overview

Tarceva maximum tolerated dose in mg

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: 1 yr
• Results posted on: 2015-06-18

Participant Flow

Participant milestones

Measure	Chemoradiation Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Measure	Chemoradiation n=12 Participants Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 yr

Tarceva maximum tolerated dose in mg

Outcome measures

Measure	Chemoradiation n=12 Participants Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
Tarceva Maximum Tolerated Dose in mg	150 mg

SECONDARY outcome

Timeframe: Within 30 days of completing radiation

Outcome measures

Measure	Chemoradiation n=12 Participants Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
Number of Dose Limiting Toxicities	0 Events

SECONDARY outcome

Timeframe: 1 year

One year survival from time of diagnosis for patients who completed this regimen

Outcome measures

Measure	Chemoradiation n=12 Participants Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
One Year Overall Survival From Time of Diagnosis	6 participants

Adverse Events

Chemoradiation

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chemoradiation n=12 participants at risk Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
Gastrointestinal disorders Anorexia	58.3% 7/12 • Number of events 7
Gastrointestinal disorders Diarrhea	41.7% 5/12 • Number of events 5
Gastrointestinal disorders Nausea	66.7% 8/12 • Number of events 8
Skin and subcutaneous tissue disorders Rash	66.7% 8/12 • Number of events 8
Gastrointestinal disorders Vomiting	58.3% 7/12 • Number of events 7
Vascular disorders Hypertension	25.0% 3/12 • Number of events 3
Renal and urinary disorders Proteinuria	16.7% 2/12 • Number of events 2

Additional Information

Dr. Brian Czito

Duke University

Phone: 919-668-7336

Email: brian.czito@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place